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EC number: 208-358-1 | CAS number: 524-38-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The skin sensitization potential of 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was estimatedby SSS (2017) using OECD QSAR toolbox v3.4 with log kow as the primary descriptor and considering the six closest read across substances. 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was predicted to be non sensitizing to the skin of guinea pig.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is predicted using OECD QSAR toolbox version 3.4 and the supporting QMRF report has been attached.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.4.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
- Specific details on test material used for the study:
- - IUPAC name: 2-hydroxy-1H-isoindole-1,3(2H)-dione
- Molecular formula: C8H5NO3
- Molecular weight: 163.132 g/mol
- Smiles notation: c12c(C(=O)N(C1=O)O)cccc2
- InChl: 1S/C8H5NO3/c10-7-5-3-1-2-4-6(5)8(11)9(7)12/h1-4,12H
- Substance type: Organic
- Physical state: Solid - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available.
- Route:
- other: No data available.
- Route:
- other: No data available.
- No. of animals per dose:
- No data available.
- Details on study design:
- No data available.
- Challenge controls:
- No data available.
- Positive control substance(s):
- not specified
- Statistics:
- No data available.
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- No skin sensitization reaction observed.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Non sensitizer
- Conclusions:
- The skin sensitization potential of 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was estimated by using OECD QSAR toolbox v3.4 with log kow as the primary descriptor and considering the six closest read across substances. 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was predicted to be non sensitizing to the skin of guinea pig.
- Executive summary:
The skin sensitization potential of 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was estimated by using OECD QSAR toolbox v3.4 with log kow as the primary descriptor and considering the six closest read across substances. 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was predicted to be non sensitizing to the skin of guinea pig.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "S M W N"
Estimation method: Takes highest mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and "i" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Imides (Acute toxicity) by
US-EPA New Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Aryl AND Fused saturated
heterocycles AND Hydroxamic acid AND Imide AND N-Hydroxylamine
derivatives by Organic Functional groups
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aryl AND Fused saturated
heterocycles AND Hydroxamic acid AND Imide AND Overlapping groups by
Organic Functional groups (nested)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Amide, aromatic attach [-C(=O)N]
AND Aromatic Carbon [C] AND Carbonyl, olefinic attach [-C(=O)-] AND
Carbonyl, one aromatic attach [-C(=O)-] AND Hydroxy, nitrogen attach
[-OH] AND Miscellaneous sulfide (=S) or oxide (=O) AND Nitrogen, two or
tree olefinic attach [>N-] AND Olefinic carbon [=CH- or =C<] AND Oxygen,
nitrogen attach [-O-] AND Oxygen-subtution at N on [-CO-N-CO-] by
Organic functional groups (US EPA)
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Aromatic compound AND Carbonic
acid derivative AND Carboxylic acid derivative AND Heterocyclic compound
by Organic functional groups, Norbert Haider (checkmol)
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.4
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Anhydrides (sulphur analogues of
anhydrides) OR Acylation >> Direct acylation involving a leaving group
>> N-Haloacylamides OR Acylation >> Ester aminolysis or thiolysis OR
Acylation >> Ester aminolysis or thiolysis >> Activated aryl esters OR
AN2 OR AN2 >> Michael addition to alpha, beta-unsaturated acids and
esters OR AN2 >> Michael addition to alpha, beta-unsaturated acids and
esters >> alpha,beta-Unsaturated Carboxylic Acids and Esters OR Michael
addition OR Michael addition >> Michael addition on conjugated systems
with electron withdrawing group OR Michael addition >> Michael addition
on conjugated systems with electron withdrawing group >>
alpha,beta-Carbonyl compounds with polarized double bonds OR Schiff
base formation OR Schiff base formation >> Schiff base formation with
carbonyl compounds OR Schiff base formation >> Schiff base formation
with carbonyl compounds >> Aldehydes OR Schiff base formation >> Schiff
base formation with carbonyl compounds >> Aromatic carbonyl compounds OR
SN2 OR SN2 >> SN2 Reaction at a sp3 carbon atom OR SN2 >> SN2 Reaction
at a sp3 carbon atom >> Activated alkyl esters and thioesters by
Protein binding by OASIS v1.4
Domain
logical expression index: "h"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -3.42
Domain
logical expression index: "i"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 2.33
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
In different studies,2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pig and human for target chemical2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) .The predicted data using the OECD QSAR toolbox has also been compared with the experimental data of target chemical.
The skin sensitization potential of 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was estimatedby SSS (2017) using OECD QSAR toolbox v3.4 with log kow as the primary descriptor and considering the six closest read across substances. 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) was predicted to be non sensitizing to the skin of guinea pig.
It is supported by experimental study conducted by S. FREGERT et al. (CONTACTDERMATITIS; 1983) to evaluate the skin sensitizing potential of target substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) in Human. Patch test was conducted for 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)on human .A 2-hydroxy-1H-isoindole-1,3(2H)-dione atdilution of (0.00001)10-5 w/w and (0.000001)10-6 (w/w) in ethanol were applied by using patch on to the skin of an old man. He showedpositive reaction at 0.00001 concentration in ethanol but negative at 0.000001 concentration in ethanol during induction exposure. After a rest period of 4 months. At challenge ,test material at thedilution of (0.001)10-3 and (0.0001)10-4(w/w) in ethanol were applied by using patch on to the skin of same person., He showedpositive reaction at(0.001)10-3concentration in ethanol but negative at(0.0001)10-4concentration in ethanol during challenge. Therefore, the substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)wasconsidered to be not sensitizing to human by Patch test.
Thus based on the above predictions on 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)andapplying weight of evidence, it can be concluded that 2-hydroxy -1H-isoindole-1,3(2H)-di one is not a skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)can be considered as not classified for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus comparing the above annotations with the criteria of CLP regulation, 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)can be considered as not classified for skin sensitization.
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